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Reimagining and delivering life-changing period products everywhere

Director of Regulatory

$105k – $155k AngelList Est.
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Three years ago we launched the most innovative period product since the tampon: the menstrual disc. It had been nearly 80 years since the tampon was introduced, and our creation was quickly embraced by consumers everywhere as “life-changing.” Since that time we’ve rapidly grown our business. FLEX started as a digitally native brand with one product, and quickly grew to a family of period products sold in top national retailers including Target and CVS.

Now The Flex Company is seeking a talented, full-time Director of Regulatory Affairs to join our team to own regulatory compliance and quality at our Company. The Flex Company is fast growing, and this role is pivotal to the success of the business by ensuring our commitment to quality and compliance as we scale and by enabling us to think strategically with prioritized resources.

This role requires deep experience in regulatory affairs, quality assurance in medical devices and a mindset to manage down risk while thinking nimbly about long term projects to enhance, optimize and expand our product footprint.

If you are experienced in Regulatory Affairs and you have the ambition to work at a mission-driven startup, this is the role for you.

About You

  • You have 5+ years of Regulatory Affairs experience at a medical device company
  • You understand managing down risk while thinking strategically
  • You can define and lead long term projects from vision through execution
  • You have delivered large scale, months long projects with success
  • You are independent and collaborative
  • You are an excellent communicator, able to simplify complex, industry-specific concepts into approachable, bullet pointed emails

Responsibilities

  • Own our existing Quality Management System and enhancements to that system
  • Run our Customer Complaint process and other operational regulatory responsibilities
  • Gain international regulatory certification and registration to support strategic expansion
  • Liaise with external experts and specialist suppliers
  • Define and execute on regulatory requirements and pathways for upcoming products

Requirements

  • Experience within FDA regulated products in the medical device consumer products organization(s) leading to premarket submissions with a track record of approvals
  • 5+ years of experience in the medical device industry
  • Bachelor's degree in a life-science/ analytical field or equivalent
  • Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences including executive leadership
  • Ability to thrive in a collaborative and fast-paced environment with a willingness to wear multiple hats when necessary
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Ability to influence without direct authority
  • Demonstrated ability to manage external vendors/consultants
  • Ability to interact and effectively communicate professionally with all levels of the organization

Nice to Haves

  • Experience working with startupsExperience in with Class II Exempt devices
  • Experience with menstrual care products
  • Master's, or Ph.D. degree in a life-science/ analytical field or equivalent
  • Track record of receiving the FDA in an audit
  • Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented appropriate and clear and conclusions are adequately supported by data

Our Shared Values

  • Choose Love Over Fear: You make sound decisions from a belief in yourself, others, or opportunities rather than out of fear.
  • Optimize For Trust: You have a track record of taking accountability for mistakes rather than blaming others. You communicate needs, concerns, and feedback directly with colleagues.
  • Have a Growth Mindset: You take constructive feedback well and actively seek feedback from colleagues. You are self-motivated to generate your best work and make a greater impact everyday.
  • Be You: You are comfortable being your authentic self at work (including in the interview!).

Medical, dental & vision

90% of benefits paid, 80% of dependents

Growing families

12 weeks of paid leave

Stock options

Equity participation for all employees

Fully unplugged time off

17 days of PTO + national holidays

Four-legged friends welcomed

Dog-friendly office with plenty of playmates

Annual learning credit

$1,000 credit towards professional development

Plenty of teambuilding

Two company off sites, happy hours and organic social events

The Flex Company at a glance

Reimagining and delivering life-changing period products everywhere

The Flex Company focuses on E-Commerce, Medical Devices, Consumer Goods, Women-Focused, and Sex. Their company has offices in Venice Beach and Venice. They have a small team that's between 11-50 employees. To date, The Flex Company has raised $4.12M of funding; their latest round was closed on October 2016.

You can view their website at http://www.flexfits.com or find them on Twitter, Facebook, and LinkedIn.

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